The NTU JO-SMART Study (NCT07317310) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
The NTU JO-SMART Study
Taiwan312 participantsStarted 2026-08-01
Plain-language summary
This study recruits patients with coexisting obesity and knee osteoarthritis (KOA) to implement the NTU-JO Smart Program, an innovative intervention integrating AI-assisted community-based exercise with continuous glucose monitoring (CGM). The primary objective is to investigate whether this intervention can improve glycemic control in this comorbid population. Other outcome measures include the risk of total knee arthroplasty (TKA), body weight changes, pain intensity scores, bone mineral density (BMD), cognitive function, as well as the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) and Patient-Reported Outcomes Measurement Information System (PROMIS) scores, which reflect the patients' overall functional status. The project also sought to explore the long-term association of the NTU-JO Smart Program with the development of type 2 diabetes (T2D) and major renal events, thereby facilitating patient-centered early treatment.
Who can participate
Age range
18 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Age: 18 to 75 years.
* Obesity status: body mass index (BMI) ≥ 27 kg/m², consistent with the obesity definition defined by the Health Promotion Administration, Ministry of Health and Welfare, Taiwan.
* Diagnosis of KOA in at least one knee according to the American College of Rheumatology (ACR) criteria, with a Kellgren-Lawrence (KL) grade of 1, 2, or 3.
* Symptomatic disease: defined as a WOMAC pain subscale score (range 0-20) greater than 4 at screening.
* Sedentary lifestyle: defined as less than 30 minutes of physical activity per week for the past 6 months.
* Informed consent: willing and able to provide written informed consent and comply with all longitudinal study procedures.
* Comorbid status: participants may be included regardless of a baseline diagnosis of T2D or CKD. Stratified randomization and subgroup analyses will be conducted based on these baseline conditions.
Exclusion Criteria:
* KL grade 4 KOA in either knee.
* Diagnosis of inflammatory arthritis, such as rheumatoid arthritis or psoriatic arthritis.
* Knee arthroscopy within the past 3 months or previous surgical history of TKA.
* Recent receipt of intra-articular injections (e.g., corticosteroids, hyaluronic acid) within the past 3 months.
* Documented history of osteoporotic fracture in hospital or cloud-based medical records.
* Type 1 diabetes.
* Presence of conditions precluding safe participation in an exercise program, such as unstable cardiovascular disease or severe neuro…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Number of participants with worsening glycemic control over 6 months
Timeframe: From enrollment to the end of intervention at 6 months